Medical Device Authority - Ministry of Health Malaysia - Downloads

TRANSITION PLAN FOR

THE IMPLEMENTATION

OF MEDICAL DEVICE

ACT 2012 (ACT 737)

MEDICAL DEVICE CONTROL DIVISION, Ministry of Health Malaysia ●

Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya●

www.mdb.gov.my ● [email protected] ●Tel: 603-88850600 ● Fax: 603-88850759

Seminar on

MEDICAL DEVICE ACT 2012 (ACT 737)PICC, Putrajaya

28 June 2012

http://www.mdb.gov.my/

mailto:[email protected]

Medical Device Control Division

MINISTRY OF HEALTH MALAYSIA

PRE-MARKET ASSESSMENT

Manufacturers of medical

devices shall -

• ensure their products

conform to EPSP

• establish appropriate quality

system for manufacturing

their products

• collect evidence of

conformity

MDA monitors compliance to requirements & takes appropriate

actions in accordance with the provisions of the law

PRE-MARKETPLACEMENT ON-

MARKETPOST-MARKET

MEDICAL DEVICE

REGISTRATION

• Manufacturers (or LARs) apply

to register medical devices &

establishment license

ESTABLISHMENT LICENSING

Importers/distributors shall -

• ensure compliance to GDP &

advertising requirements

• apply for establishment license

to import/distribute medical

devices

SURVEILLANCE & VIGILANCE

Establishments shall -

• monitor safety & performance

of products

• carry out post-market

obligations, eg complaint

handling, FSCA, recall

USAGE & MAINTENANCE

• Users shall use, maintain &

dispose off medical devices

appropriately

• Users shall apply for permit to

use/operate designated medical

devices

CAB verifies evidence of

conformity

OVERVIEW OF THE REGULATORY

FRAMEWORK



• A classification of medical devices based on risk associated with the vulnerability of the human body, the technical design and the manufacture of the medical device

Class Risk Level Device examples

A Low Simple surgical instruments, tongue depressor, liquid-in-glass thermometer, examination light, simple wound dressing, oxygen mask, stethoscopes, walking aids

B Low-Moderate

Hypodermic needles, suction equipment, anesthetic breathing circuits, aspirator, external bone growth simulators, hearing aids, hydrogel dressings, patient controlled pain relief, phototherapy unit, x-ray films

C High-Moderate

Lung ventilator, orthopedic implants, baby incubator, blood oxygenator, blood bag, contact lens disinfecting/cleaning products, deep wound dressing, defibrillator, radiological therapy equipment, ventilator

D High Pacemakers and their leads, implantable defibrillators, implantable infusion pumps, heart valves, inter-uterine contraceptive devices, neurological catheters, vascular prostheses, stents

It uses a set of classification rules based on: intended use

duration of use (transient, short-term and long-term)

part of human body (non-invasive or invasive with respect to body orifices, surgically invasive interventions, central circulatory system, central nervous system)

A

B

C

DR I S K

Device risk/class

Reg

ula

tory

co

ntr

ol

RISK-BASED CLASSIFICATION &

REGULATORY CONTROL



Conformity assessment (CA):

Systematic examination of evidence

generated and procedures

undertaken by the manufacturer

under the requirements established

by the Regulatory Authority to

determine that a medical device is

safe and performs as intended by

the manufacturer and, therefore,

conforms to the Essential Principles

of Safety and Performance for

Medical Devices

What To Look For In CA?

Objective evidence for

conformance to Essential

Principles of Safety &

Performance of Medical

Device –

6 general principles

11 design and manufacturing

principles

CONFORMITY ASSESSMENT



General Principles

Medical device should be designed & manufactured in such a way that:

no compromise to clinical condition or safety of patients, or safety and health of users or other persons

control the risk so that residual risk is brought down to an acceptable level

suitable for one or more of the functions within the scope of the definition of a medical device

characteristics and performances should not be adversely affected to such a degree that they compromise the health or safety of patient or user and other persons during the lifetime of the device

characteristics and performances during their intended use will not be adversely affected under transport and storage conditions

benefits must be determined to outweigh any undesirable side effects

Design and Manufacturing Principles

Chemical, physical and biological properties

Infection and microbial contamination

Manufacturing and environmental properties

Devices with a diagnostic or measuring function

Protection against radiation

Requirements for medical devices connected to or equipped with an energy source

Protection against mechanical risks

Protection against the risks posed to the patient by supplied energy or substances

Protection against the risks posed to the patient for devices for self-testing or self-

administration

Information supplied by manufacturer

Performance evaluation including where appropriate, clinical evaluation

Essential Principles of Safety & Performance of Medical Device




Elements of CA

QMS (ISO 13485 or equivalent, GDPMD)

Post-market surveillance system (GHTF recommendations)

Summary technical documentation (ASEAN CSDT)

Declaration of conformity (DoC) (GHTF recommendations)

Registration of medical device & licensing of establishment

Quality Mgmt System (QMS)

• For manufacturer, ISO 13845 or equivalent

–Class A & B products, can exclude design control, process control, inspection & testing

–For Class C, full QMS

–For Class D, full QMS

• PMS system

• Technical evaluation of sterilization process (if any)

• For LAR, importer, distributor: GDPMD

Post-Market Surveillance

System (PMS)

• Distribution records

• Complaint records

• Adverse incident reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices)

• FSCA reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Content of Field Safety Notices)

Summary Technical Documentation

• Format – ASEAN CSDT

• Compliance to EPSP (GHTF recommendations - Essential Principles of Safety & Performance of Medical Devices)

• Acceptable standards or equivalence will be widely used (GHTF recommendations -Role of Standards in the Assessment of Medical Devices)

• CAB determines the adequacy of the documented evidence to support attestation of conformity

Declaration of Conformity

(DoC)

• A DoC is a declaration made by the manufacturer of a device that the device is in conformity with the regulatory requirements

• DoC declares that the manufacturer guarantees that each piece of the device sold is in conformity with the regulatory requirements




Conformity assessment is primarily the

responsibility of the medical device manufacturer.

However, it is done in the context of the

established regulatory requirements and both

the process and conclusions are subject to further review by the

Regulatory Authority

CAB reviews evidence of conformity

Authority reviews & registers product

& licenses establishment

What is a CAB?

A body authorized by the Authority to perform specified CA activities to determine whether the relevant requirements in technical regulations or standards are fulfilled

CAB is independent of the organization that provides the product and is not a user of the product (3rd party)

Authority will monitor the performance of the CAB and, if necessary, withdraw authorization

CA PROCESS & PARTIES INVOLVED

Manufacturerconducts CA on;(i) QMS & PMS(ii) Product safety & performance (summary tech doc & DoC





Class QMS PMS systemTech doc

CSDTDoC

Registration

& licensing

Class A,

Class A(S)

Class A(M)

Est & maintain –

can excl design &

dev control. Class A

may be audited for

special cases. For

Class B, make

available for audit

Establish &

maintain adverse

event reporting

procedure for

audit. For Class

A, audit may be

required to

investigate

specific safety or

regulatory

concerns

Prepare, make

available upon

request. For

Class B may

be reviewed for

conformity to

EPSP

Prepare,

sign &

submit

for

review

Perform

according to

requirementsClass B

Class C Establish, maintain

full QMS make

available for audit

Prepare &

submit for

reviewClass D

Level of CA A –

Se

lf

decla

re

B

C

D –

Pro

du

ct design

&

man

ufactu

ring co

ntro

l

R I S K

The level of CA is proportional to the

risk associated with the device



WHAT DO WE NEED TO IMPLEMENT THE

REGULATORY SYSTEM?

• Legal support, ie the Acts

• Subsidiary legislations & guidance documents

• Medical Device Authority & organization

• Registration & licensing system– Internal processes & procedures

– Register, database & resource center

– Forms

– Criteria

– Procedures



r

MEDICAL DEVICE REGISTRATION ROUTES

A

Medical

device?

Class?

Class A Sterile MD

-ISO 13485 (In-House)

-ISO 13485 (Sterile Services)

-Process Validation (Report)

Class A Measuring Function MD

-Process Validation (Report)

Decision

B, C, D

Pay fee

MEDICAL

DEVICE

REGISTER

Grouping:

• Single

• System

• Kits

• Group

1.Application Form

2. DC from Product Owner/Manufacturer

3.CSDT

4. Class B, C if Required- Clinical evidence

Class C&D – Clinical Evaluation

Yes

Yes

No

Stop

Stop

No

Qualified

for

abridged?

No

Conformity Assessment By CAB or MDA

1. Technical File

2. ISO 13485 QMS

Yes

Evaluation

B, C, D

OK?

Class A

1.Application Form

2. Declaration of conformity

3. Certified QMS. If no, attestation by manufacturer

4. Simplified CSDT

Yes



LICENSING OF ESTABLISHMENTS

Imported device

Importer

Authorized

representative

Foreign

manufacturer

Distributor

Local

manufacturer

Distributor

Relationship between different

establishments

Locally-made device

Establishment means a

person/organization who is

either a manufacturer,

authorized representative (for

foreign manufacturer), importer

or distributor of medical

devices, but does not include a

retailer

Different type of establishment

has different roles &

responsibilities – different set

of control

Establishment must possess

valid license to carry out

activities related to medical

devices in Malaysia



Manufacturer as defined in Section 2 of MD Bill 2011: definition of “manufacturer”

Authorized representative as defined in Section 2 of MD Bill 2011: definition of “manufacturer”

• Authorized representative must be natural or legal person with business registration in Malaysia.

• It must maintain linkage with its foreign manufacturer and should be able to obtain the support of its foreign manufacturer whenever required.

Distributor: Any natural or legal person in the supply chain authorized by the manufacturer/authorized representative to further the availability of medical devices to the end-user. In some circumstances, more than one distributor may be involved in this process

Importer: Any natural or legal person authorized by authorized representative, who first makes a medical device manufactured in other countries, available in the Malaysian market

Authorization: Appropriate authorization from the respective establishment is required as a pre-requisite for the issuance of license

Authorized rep must be authorized by foreign manufacturer

Importer must be authorized by authorized rep to import devices on its behalf

Distributor must be authorized by manufacturer/ authorized rep to distribute devices on its behalf

An entity may apply for license for different types of establishment





Requirements Local

manufacturer

Authorized

repImporter Distributor

• Establishment details

• Appropriate authorization

• Procedures for;

– Distribution records

– Complaint handling

– Adverse incident reporting

– Field safety corrective

action

• List of medical devices

• ISO 13485 or equivalent

• Good Distribution Practice for

Medical Devices (GDPMD)



GDPMD FOR AUTHORIZED REP,

IMPORTER & DISTRIBUTOR

Imported medical devicesDistributor

Importer

Local

authorized

representative

Foreign

manufacturer

Distributor

Importer

Local

manufacturer

Distributor

Locally-made medical devices



SAVINGS & TRANSITIONAL

Section 80 of MD Act 2012 (Act 737): Savings and

transition

– All medical devices shall be registered within 24

months from the appointed date

– All establishments shall be licensed within 12 months

from the appointed date



CURRENT STATUS: THE ACT

• MD Act 2012 (Act 737) & MD Authority 2012

(Act 738)

– 3 Oct 2011: Passed by Lower House of Parliament

– 7 Dec 2011: Passed by Upper House of Parliament

– Already gazetted



CURRENT STATUS: ORGANIZATION

• New statutory body setup: Medical Device Authority – early Q3 2012

• Human resource – already approved PSD

MEDICAL DEVICE

AUTHORITY (MDA)

A body corporate with the following

members

-DG of Health as the Chairman

-Chief Executive of the MDA

- a representative of Min of Finance

- a representative of Min of Health

-not more than five persons

appointed by the Minister, who have

expertise and experience in medical

device matters

Functions of MDA

•To implement, enforce, consider and recommend reform

to the medical device laws

•To perform the following

- to regulate all matters

- to provide consultancy & advisory service and any

other services

in relation to medical device, its industries and activities

•To utilize property of the Authority in such manner as the

Authority may think expedient

•To impose fees or charges for services rendered

Committees appointed by MDA

- to assist in the performance of the functions of the Authority



CURRENT STATUS: SUBSIDIARY

LEGISLATIONS

• MD (Pre-Market) Regulations

– 1st phase: draft pre-market regulations is ready• Registration of MD

– Classification

– Grouping

– Conformity assessment procedure

– Application procedure for registration

– Renewal of registration

– Changes concerning registered MD

– Exemption

– Cancellation of registration

• Registration CAB

• Establishment license

• Etc..

– To be submitted to AG’s Chamber: August 2012

• Forms

• Fee structure

• Criteria

• Conditions

• Procedures

• Other details



CURRENT STATUS: GUIDANCE

DOCUMENTS

Awaiting publication Under development

(i) Definition of Medical

Device

(ii) Risk Based

Classification

(iii) Essential Principles of

Safety & Performance

of Medical Device

(iv)Common Submission

Dossier Template

(v) Good Distribution

Practice for Medical

Devices

(vi) IVD Medical Device

Classification System

(vii) Essential Principles

of Safety and

Performance for IVD

Medical Devices

(viii) Conformity

Assessment for IVD

Medical Devices

(ix) Common Submission

Dossier Template for

IVD Medical Device

(i) Conformity assessment

body

(ii) Declaration of

Conformity

(iii) Guidelines for product

registration

(iv)Grouping of medical

devices

Guidance Documents



REGISTRATION OF MEDICAL DEVICES

Medical device regulatory system

is based on safety & performance

of medical devices throughout

their life cycle

Prior to registration of a medical

device, CA is conducted to

provide objective evidence of

safety & performance a medical

device

Only registered medical devices

can be placed into the market

Establishments dealing with

medical devices must comply

with conditions and carry out

their obligations

Who shall be responsible?

– Licensed local manufacturers or authorized rep

What would be required?

– Submission of CSDT

– Submission of DoC

– Establishment, maintenance and making available of QMS & PMS documents for audit

Upon approval, the medical device will be put in the Medical Device Register

Abridged Assessment

• Applicable for medical devices which have already approved by the relevant authority to be marketed in US, EU, Canada, Australia, Japan.

• Otherwise, full assessment shall be done



CURRENT STATUS: MEDC@ST

• New registration & licensing system

ESTABLISHMENT LICENSING

MEDICAL DEVICE REGISTRATION

CAB REGISTRATION

COMPETENCY REGISTRATION

SERVICE PROVIDER REGISTRATION



MEDC@ST: ESTABLISHMENT LICENSING

Authorized representative



MEDC@ST: MEDICAL DEVICE

REGISTRATION



MEDC@ST: MEDICAL DEVICE

REGISTRATION



NOW TO MANDATORY PHASE

Preparation & development of

MD Act


computerized system


subsidiary legislations

Appointment of members of

MD Authority

Appointment of Chief

Executive of MD Authority

Transition of MD Control Div to assist in

the establishment of MD Authority

Preparation & development of regulations, guidance documents & standards for the implementation of MD Act

Passing

of MD &

MD

Authority

Bills

3-Oct-2011

Gazette-

ment of

MD &

MD

Authority

Bills

30-Dec-2011

Announcement

of appointed

dates of

implementation

MD & MD

Authority Acts

End Feb2 012

Establish-

ment of

MD

Authority

31-July-2012

Appointed

date of

implement-

ation of MD

Act

31-Oct-2012

Mandatory

implementation

MD Act

31-Oct-2014



Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2011 2012 2013 2014 2015

Voluntary Transition Mandatory

Gazettement of Bills

Passing of Bills

Establishment of MD

Authority

Appointed dates of

implementation MD Act

Mandatory implementation

of MD Act


Reg

istr

ati

on

of

Pro

du

cts

an

d C

AB

s

Phase 1: Registration of Class A

Phase 2: Registration of CAB

Phase 3: Registration of Class D

Phase 4: Registration of Class B &C

Phase 5: Registration of IVD

Lic

en

sin

g o

f

Es

tab

lis

hm

en

ts

Phase 3: Imposition of other obligations

Phase 2: Imposition of GDP for other establishments

Phase 1: Imposition of ISO13485 for manufacturers



June July August September October


Development

of GD

Development of CAB registration system

Implementation of

CAB registration

Finalization of GD

Comments of GD from

interested parties

CAB Registration System

CA

B g

uid

an

ce

do

cu

me

nt (G

D)

CA

B r

eg

istr

ation

syste

m



SUMMARY

• Regulatory framework & legal support are in

place

• Current status: Work is progressing – putting

the detailed pieces together

• Moving forward – regulatory activities will be

introduced in phases, timeline

• Awareness & consultations



….Thank you for your attention